Alcohol Use, HIV Positive
Conditions
Brief summary
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions
Detailed description
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels. Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level. Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.
Interventions
BEHAVIORALComputerized Brief Intervention (CBI)
A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits.
BEHAVIORALCBT4CBT
9 computerized modules delivered at the participant's pace
DRUGRecommendation and Counseling for Alcohol Pharmacotherapy
The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were given varying levels of treatment depending on their alcohol use.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years or older; * Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months; * AUDIT-C score \> 3 women or \> 4 men at time of PRO.
Exclusion criteria
* Non-English speaking; * Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audit-C Score on a Scale | 18 month window | Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PEth Levels | Between baseline and 6 month follow-up | PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risky Drinking, no dx of AUD, Has Panic or Depression Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits.
CBT4CBT: 9 computerized modules delivered at the participant's pace | 115 |
| Dx of AUD With or Without Panic or Depression Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol.
Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits.
CBT4CBT: 9 computerized modules delivered at the participant's pace
Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. | 27 |
| No dx of Alcohol Use Disorder, Panic or Depression This arm will receive standard of care services at each clinic. | 4,843 |
| Total | 4,985 |
Baseline characteristics
| Characteristic | Dx of AUD With or Without Panic or Depression | No dx of Alcohol Use Disorder, Panic or Depression | Risky Drinking, no dx of AUD, Has Panic or Depression | Total |
|---|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 11 | 49 years STANDARD_DEVIATION 12 | 48 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Hispanic | 9 Participants | 649 Participants | 11 Participants | 669 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 8 Participants | 2151 Participants | 55 Participants | 2214 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 9 Participants | 1839 Participants | 45 Participants | 1893 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 204 Participants | 4 Participants | 209 Participants |
| Sex: Female, Male Female | 3 Participants | 969 Participants | 22 Participants | 994 Participants |
| Sex: Female, Male Male | 24 Participants | 3874 Participants | 93 Participants | 3991 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 27 | 0 / 4,843 |
| other Total, other adverse events | 0 / 115 | 0 / 27 | 0 / 4,843 |
| serious Total, serious adverse events | 0 / 115 | 0 / 27 | 0 / 4,843 |
Outcome results
Primary
Audit-C Score on a Scale
Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Time frame: 18 month window
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Risky Drinking, no dx of AUD, Has Panic or Depression | Audit-C Score on a Scale | -1.0 score on a scale |
| Dx of AUD With or Without Panic or Depression | Audit-C Score on a Scale | -2.3 score on a scale |
| No dx of Alcohol Use Disorder, Panic or Depression | Audit-C Score on a Scale | -1.0 score on a scale |
Secondary
PEth Levels
PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels.
Time frame: Between baseline and 6 month follow-up
Population: As a result of the COVID pandemic, sample collection was disrupted, leading to only 13 samples collected overall. This number of samples was below the 75% threshold needed to justify processing the samples. Samples were never sent for PeTH testing and will not be sent for PeTH testing.